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Abstract

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) provides an abbreviated approval pathway for biological therapeutic products shown to be biosimilar to an FDA-approved biological reference product. The BPCIA purported to reduce the price of biologics while promoting innovation. In two recent cases, the Federal Circuit interpreted a key provision of the BPCIA requiring an applicant to provide the reference product sponsor with notice 180 days before marketing the product. The Federal Circuit’s interpretation extends the exclusivity period already provided for the reference product sponsor, deterring innovation and price reduction. Thus, the Supreme Court granted certiorari in one of the cases.

This Note will examine provisions of the BPCIA, discuss the two recent Federal Circuit decisions, offer an interpretation of the relevant BPCIA provisions and a proposed stance on the issues before the Supreme Court, and explain how the current interpretation impairs the potential for a generic market for biologics.